morphine sulfate

Generic: morphine sulfate

Labeler: international medication systems, limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler international medication systems, limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

morphine sulfate 1 mg/30mL

Manufacturer
International Medication Systems, Limited

Identifiers & Regulatory

Product NDC 76329-1912
Product ID 76329-1912_99799101-d92b-485b-93ec-f2b5a2e5ca26
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202861
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-01-20

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 763291912
Hyphenated Format 76329-1912

Supplemental Identifiers

UNII
X3P646A2J0

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name morphine sulfate (source: ndc)
Generic Name morphine sulfate (source: ndc)
Application Number ANDA202861 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/30mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (76329-1912-1) / 30 mL in 1 VIAL (76329-1912-0)
source: ndc

Packages (1)

76329-1912-1 10 VIAL in 1 PACKAGE (76329-1912-1) / 30 mL in 1 VIAL (76329-1912-0)

Ingredients (1)

morphine sulfate (1 mg/30mL)

Linked Drug Pages (1)

Morphine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "99799101-d92b-485b-93ec-f2b5a2e5ca26", "openfda": {"unii": ["X3P646A2J0"], "spl_set_id": ["1034467f-d436-4b87-a902-c7e8885daa8a"], "manufacturer_name": ["International Medication Systems, Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (76329-1912-1)  / 30 mL in 1 VIAL (76329-1912-0)", "package_ndc": "76329-1912-1", "marketing_start_date": "20220120"}], "brand_name": "Morphine Sulfate", "product_id": "76329-1912_99799101-d92b-485b-93ec-f2b5a2e5ca26", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "76329-1912", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "International Medication Systems, Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "1 mg/30mL"}], "application_number": "ANDA202861", "marketing_category": "ANDA", "marketing_start_date": "20220120", "listing_expiration_date": "20261231"}